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Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2
Completed
Conditions
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Registration Number
NCT00086892
Lead Sponsor
Gynecologic Oncology Group
Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of cetuximab and carboplatin in patients with recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

* Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (75)

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

MBCCOP - University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Tufts - New England Medical Center

🇺🇸

Boston, Massachusetts, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

Duke Comprehensive Cancer Center

🇺🇸

Durham, North Carolina, United States

Charles M. Barrett Cancer Center at University Hospital

🇺🇸

Cincinnati, Ohio, United States

MBCCOP - Hawaii

🇺🇸

Honolulu, Hawaii, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

🇺🇸

Orange, California, United States

Jonsson Comprehensive Cancer Center at UCLA

🇺🇸

Los Angeles, California, United States

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

Fox Chase-Temple Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

UPMC Cancer Center at Magee-Womens Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Virginia Cancer Center

🇺🇸

Charlottesville, Virginia, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Gynecologic Oncology Network

🇺🇸

Greenville, North Carolina, United States

Australia New Zealand Gynaecological Oncology Trials Group

🇦🇺

Camperdown, New South Wales, Australia

Abramson Cancer Center of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

🇺🇸

Columbus, Ohio, United States

University of Wisconsin Comprehensive Cancer Center

🇺🇸

Madison, Wisconsin, United States

CCOP - Scott and White Hospital

🇺🇸

Temple, Texas, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

MultiCare Regional Cancer Center at Tacoma General Hospital

🇺🇸

Tacoma, Washington, United States

CCOP - Marshfield Clinic Research Foundation

🇺🇸

Marshfield, Wisconsin, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

🇺🇸

Denver, Colorado, United States

Comprehensive Cancer Center at University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of Oklahoma College of Medicine

🇺🇸

Oklahoma City, Oklahoma, United States

CCOP - Columbia River Oncology Program

🇺🇸

Portland, Oregon, United States

Siteman Cancer Center at Barnes-Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

M.D. Anderson Cancer Center at University of Texas

🇺🇸

Houston, Texas, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

🇺🇸

Tampa, Florida, United States

CCOP - Michigan Cancer Research Consortium

🇺🇸

Ann Arbor, Michigan, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

🇺🇸

Omaha, Nebraska, United States

Comprehensive Cancer Center at Wake Forest University

🇺🇸

Winston-Salem, North Carolina, United States

Women's Cancer Center - Los Gatos

🇺🇸

Los Gatos, California, United States

CCOP - Christiana Care Health Services

🇺🇸

Newark, Delaware, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

CCOP - Evanston

🇺🇸

Evanston, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Holden Comprehensive Cancer Center at University of Iowa

🇺🇸

Iowa City, Iowa, United States

UMASS Memorial Cancer Center - University Campus

🇺🇸

Worcester, Massachusetts, United States

CCOP - Grand Rapids

🇺🇸

Grand Rapids, Michigan, United States

CCOP - Kalamazoo

🇺🇸

Kalamazoo, Michigan, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

University of Minnesota Cancer Center

🇺🇸

Minneapolis, Minnesota, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia

🇺🇸

Columbia, Missouri, United States

CCOP - Cancer Research for the Ozarks

🇺🇸

Springfield, Missouri, United States

SUNY Downstate Medical Center

🇺🇸

Brooklyn, New York, United States

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

Long Island Cancer Center at Stony Brook University Hospital

🇺🇸

Stony Brook, New York, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Southeast Gynecologic Oncology Associates

🇺🇸

Knoxville, Tennessee, United States

Fred Hutchinson Cancer Research Center

🇺🇸

Seattle, Washington, United States

Saint Joseph Regional Medical Center

🇺🇸

South Bend, Indiana, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center

🇺🇸

Lexington, Kentucky, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

🇺🇸

Dallas, Texas, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

CCOP - Geisinger Clinic and Medical Center

🇺🇸

Danville, Pennsylvania, United States

Keesler Medical Center - Keesler Air Force Base

🇺🇸

Keesler AFB, Mississippi, United States

North Shore University Hospital

🇺🇸

Manhasset, New York, United States

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

🇺🇸

Camden, New Jersey, United States

Kagoshima City Hospital

🇯🇵

Kagoshima City, Japan

CCOP - Western Regional, Arizona

🇺🇸

Phoenix, Arizona, United States

Norwegian Radium Hospital

🇳🇴

Oslo, Norway

Vanderbilt-Ingram Cancer Center

🇺🇸

Nashville, Tennessee, United States

Tom Baker Cancer Centre - Calgary

🇨🇦

Calgary, Alberta, Canada

Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

🇺🇸

Burlington, Vermont, United States

Yale Comprehensive Cancer Center at Yale University School of Medicine

🇺🇸

New Haven, Connecticut, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

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